Uterine electrical stimulation system and method

ABSTRACT

Systems and methods for applying stimulating current to a patient for treating insufficient uterine contractions are provided. The system includes stimulation electrodes of a balloon electrode array device, a ring electrode array device, an electrode probe device, or a mesh electrode array device. Some aspects of the invention also provide a connector and cable device for coupling the stimulation electrodes to electronics for generating and providing the stimulating current to the stimulation electrodes.

RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119 to U.S.Provisional Patent Application No. 61/407,397 filed on Oct. 27, 2010,the entire contents of which is incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

N/A.

BACKGROUND OF THE INVENTION

The present application is directed to systems and methods for applyingstimulating current to a patient for treating insufficient uterinecontractions.

Postpartum hemorrhage, which is a significant source of maternalmorbidity and mortality in modern obstetrics, occurs in up to 18 percentof births (1,2). Even with appropriate management, approximately 3-4percent of vaginal deliveries result in severe postpartum hemorrhage inthe United States and in other developed nations (3), which can resultin occult myocardial ischemia, dilutional coagulopathy, and death (4).While sudden death can occur from rapid and uncontrolled postpartumhemorrhage because of brisk blood loss, many deaths are the result ofineffective management of continuous low-level bleeding (5). Inless-developed countries and in rural areas of the United States,maternal hemorrhage is a greater issue. For example, in Zimbabwe,hemorrhage is responsible for 25 percent of maternal deaths.Approximately 125,000 women per year die worldwide due to postpartumhemorrhage (6).

Uterine atony causes more than 90 percent of cases of postpartumhemorrhage (5). Uterine atony is a loss of tone in the uterinemusculature postpartum, resulting in the failure of uterine muscles tocontract tonically and stop postpartum bleeding. This may be related tothe inability of myometrial cells in some patients to act properly aspacemakers for tonic (or phasic) contractions after delivery (7), or maybe related to changes in threshold or resting potentials brought on bythe delivery process or by administration of medications (8).

Normally, contraction of the uterine muscle compresses the vessels andreduces blood flow after delivery. This increases coagulation, whichprevents bleeding. However, lack of uterine muscle contractions cancause an acute postpartum hemorrhage. Many factors can contribute to theloss of uterine muscle tone, including overdistention of the uterus,multiple gestations, polyhydramnios, fetal macrosomia, prolonged labor,oxytocin augmentation of labor, grand multiparity (having given birth 5or more times), precipitous labor (labor lasting less than 3 hours),magnesium sulfate treatment of preeclampsia, chorioamnionitis,halogenated anesthetics, and uterine leiomyomata (9).

Current treatments for preventing blood loss during uterine atony and/oruterine rupture include radical procedures such as surgery, manualmassage, which is often minimally effective, and drugs, such asoxytocin, prostaglandins, and ergot alkyloids. Oxytocin and other drugtreatment is a common global application, however such treatment isoften not well controlled and can have dangerous side effects for boththe mother and the fetus.

SUMMARY OF THE INVENTION

The present invention provides a system for treating insufficientuterine contractions in a patient after labor and delivery. The systemincludes one or more stimulation electrodes coupled to or positionedalong one of a uterus, a cervix, a vaginal wall, and an abdominal wallof a patient to apply stimulating current to the patient in order totreat insufficient uterine contractions, and more specifically, for thepatient to produce tonic uterine contractions. The stimulationelectrodes can be part of a balloon electrode array device, a ringelectrode array device, an electrode probe device, and/or a meshelectrode array device. The system can also include electronics forgenerating and providing the stimulating current to the stimulationelectrodes. Some aspects of the invention also provide a connector andcable device for coupling the stimulation electrodes to the electronics.

In one aspect of the invention, a balloon electrode array deviceincludes at least one balloon, an access tube extending into the atleast one balloon, a plurality of lead wires routed through the accesstube and into an inside portion of the balloon, and a plurality ofelectrodes. Each one of the plurality of electrodes is coupled to one ofthe plurality of lead wires, and the plurality of electrodes extend fromthe inside portion of the balloon to an outer surface of the balloon.

In another aspect of the invention, a mesh electrode array deviceincludes a non-conductive mesh material with a plurality of segments andnodes of intersection of the plurality of segments. The mesh electrodearray device also includes a plurality of electrodes, where each one ofthe plurality of electrodes is coupled to one of the nodes ofintersection, and a plurality of lead wires. Each one of the pluralityof lead wires is coupled to one of the plurality of electrodes.

Other aspects of the invention include an electrode probe device and aring electrode array device. The electrode probe device includes asubstantially cylindrical probe with a first end and an opposite secondend, at least one electrode positioned adjacent to the first end, and atleast one lead wire electrically coupled to the at least one electrode.The ring electrode array device includes a flexible ring, a plurality ofelectrodes affixed to an outer surface of the flexible ring, and aplurality of lead wires electrically coupled to the electrodes.

In yet another aspect of the invention, a connector device includes anelectronics connector plug capable of being releasably coupled to asystem that produces stimulating current and configured to receive thestimulating current from the system. The connector device also includesa lead wire connector plug capable of being releasably coupled to anelectrode device and configured to deliver the stimulating current tothe electrode device, and a flexible, electrically insulated cableelectrically connecting the electronics connector plug and the lead wireconnector plug.

The foregoing and other aspects and advantages of the invention willappear from the following description. In the description, reference ismade to the accompanying drawings which form a part hereof, and in whichthere is shown by way of illustration a preferred embodiment of theinvention. Such embodiment does not necessarily represent the full scopeof the invention, however, and reference is made therefore to the claimsand herein for interpreting the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates different types of observable uterine contractileevents.

FIG. 2 is a graph illustrating a measured electrical power ofcontracting uterine muscles at different action potential frequencies.

FIG. 3 is a graph illustrating forces exerted by contracting uterinemuscles over time when stimulating current is applied at different pulsefrequencies.

FIG. 4 is a schematic of an in vitro setup for stimulating uterinetissue and measuring resulting contractile activity.

FIG. 5 is a graph illustrating a contractile recording of rat uterinetissue when varying pulse frequency in applied stimulation current.

FIG. 6 is a graph illustrating a contractile recording of human uterinetissue, when varying pulse frequency in applied stimulation current.

FIG. 7 is a graph illustrating a contractile recording of human uterinetissue, when varying train duration in applied stimulation current.

FIG. 8 is another graph illustrating contractile recordings of humanuterine tissue, including a control trace and a test trace, when varyingtrain duration in applied stimulation current.

FIG. 9 is another graph illustrating contractile recordings of humanuterine tissue, when varying pulse frequency outside conventionalparameters in applied stimulation current, in accordance with thepresent invention.

FIG. 10 is a schematic view of a system for use with the presentinvention.

FIG. 11 is a front cross-sectional view of a uterus.

FIG. 12A is a side cross-sectional view of a uterus normally contractingpost-partum.

FIG. 12B is a side cross-sectional view of a ruptured uterus, which isnot contracting post-partum due to uterine atony.

FIG. 12C is a side cross-sectional view of a ruptured uterus beingstimulated by the system of FIG. 10.

FIG. 13 is a side view of a balloon electrode array device for use withthe present invention.

FIG. 14A is a front cross-sectional view of the balloon electrode arraydevice of FIG. 13 in an inflated state.

FIG. 14B is a front cross-sectional view of the balloon electrode arraydevice of FIG. 13 in a deflated state.

FIG. 15A is a side view of a ring electrode array device for use withthe present invention.

FIG. 15B is a front cross-sectional view of the ring electrode arraydevice of FIG. 15A.

FIGS. 16A-16B are side views of the ring electrode array device of FIG.15A, including applicators.

FIGS. 17A-17C are perspective views of an electrode probe device for usewith the present invention.

FIGS. 18A-18B are mesh structures of a mesh electrode array device foruse with the present invention.

FIG. 19 illustrates side views of electrodes for use with the presentinvention.

FIGS. 20A-20C are perspective views of a mesh electrode array device foruse with the present invention.

FIG. 21A is a perspective view of a connector and cable device for usewith the present invention.

FIG. 21B is a perspective view of another connector and cable device foruse with the present invention.

FIGS. 22A-22B are front views of pin connector arrays of the connectorand cable device of FIGS. 21A and 21B.

FIGS. 23A-23B are schematic views of a connector pin of the pinconnector arrays of FIGS. 22A and 22B.

FIG. 24A is a perspective view of a male connector pin for use with thepin connector arrays of FIGS. 22A and 22B.

FIG. 24B is a perspective view of a female connector pin for use withthe pin connector arrays of FIGS. 22A and 22B.

DETAILED DESCRIPTION OF THE INVENTION

Before any embodiments of the invention are explained in detail, it isto be understood that the invention is not limited in its application tothe details of construction and the arrangement of components set forthin the following description or illustrated in the following drawings.The invention is capable of other embodiments and of being practiced orof being carried out in various ways. Also, it is to be understood thatthe phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof herein ismeant to encompass the items listed thereafter and equivalents thereofas well as additional items. Unless specified or limited otherwise, theterms “mounted,” “connected,” “supported,” and “coupled” and variationsthereof are used broadly and encompass both direct and indirectmountings, connections, supports, and couplings. Further, “connected”and “coupled” are not restricted to physical or mechanical connectionsor couplings. Where appropriate, the terms “stimulation” and“stimulated” are understood to refer to electrical stimulation andelectrically stimulated, respectively.

The following discussion is presented to enable a person skilled in theart to make and use embodiments of the invention. Various modificationsto the illustrated embodiments will be readily apparent to those skilledin the art, and the generic principles herein can be applied to otherembodiments and applications without departing from embodiments of theinvention. Thus, embodiments of the invention are not intended to belimited to embodiments shown, but are to be accorded the widest scopeconsistent with the principles and features disclosed herein. Thefollowing detailed description is to be read with reference to thefigures, in which like elements in different figures have like referencenumerals. The figures, which are not necessarily to scale, depictselected embodiments and are not intended to limit the scope ofembodiments of the invention. Skilled artisans will recognize theexamples provided herein have many useful alternatives and fall withinthe scope of embodiments of the invention.

Some embodiments of the invention provide a system and method oftreating uterine atony by administering electrical stimulation to theuterus. The electrical stimulation to the uterus can result in uterinemuscle contractile activity, which can aid in decreasing and/or stoppinguterine bleeding.

There are several different types of observable uterine contractileevents. As shown in FIG. 1, some uterine contractile events can includespontaneous phasic contractions (spontaneous contractions which areshort in duration and occur without outside stimulation), shortstimulated phasic contractions (stimulated contractions which areshorter in duration and stop at or before the time stimulation isstopped), long stimulated phasic contractions (stimulated contractionswhich are longer in duration and stop immediately after the timestimulation is stopped), and tonic contractions (sustained contractionswhich persist long after stimulation is stopped). During labor anddelivery, the human uterus exhibits spontaneous phasic contractions thatproduce associated electrical action potential frequencies in the rangeof 0.0 Hertz (Hz) to about 3.0 Hz. In addition, to a lesser degree, thehuman uterus also exhibits spontaneous phasic contractions duringmenstrual cycles in non-pregnant women. As shown in FIG. 2, electricalpower output of human uterine spontaneous phasic contractions is mostlyconcentrated at less than 1.0 Hz. Very little electrical power isobserved in higher frequencies than the above described range.

Current stimulation systems are used for stimulating the uterine tissuewith similar frequencies as those seen naturally, using an externalpower source to induce contractions in laboring women who experienceinsufficient contractions to adequately deliver a baby. For example,U.S. Pat. No. 6,356,777, the entire contents of which is incorporatedherein by reference, specifies the use of electrical stimulatingfrequencies in the 0.0 Hz to about 5.0 Hz range for controlling phasiccontractions. The uterus responds favorably to such electricalstimulation signals by exhibiting stimulated phasic contractions, likethose occurring naturally during labor and delivery, as shown in FIG. 3.

FIG. 3 illustrates uterine muscle activity over time when a stimulationcurrent is applied. As shown in FIG. 3, uterine muscle action returns tobaseline immediately after the current is switched off when usingfrequencies up to about 5 Hz. In some instances, the maximal contractileactivity begins to fall well before the current is turned off, which isindicative of stimulated phasic contractile activity. The stimulatedphasic contractile activity shown in FIG. 3 can be considered shortstimulated phasic contractions, as the stimulation duration issubstantially small (e.g., less than about 3 minutes) and thestimulation frequency lies within the conventional uterine stimulationfrequency range. In some embodiments, short stimulated phasiccontractions can be specified as having a minimal duration time of about30 seconds and a maximum duration time of about 3 minutes. Uterinemuscle stimulation within these established ranges and the resultingphasic contractile activity are not thought to be useful for stoppinguterine blood loss in the case of uterine rupture and postpartumhemorrhage.

FIG. 4 illustrates an in vitro setup 10 for stimulating uterine tissueand measuring resulting contractile activity. The setup includes one ormore strips 12 (i.e., strips of uterine muscle tissue) outfitted with aplurality of stimulation electrodes 14 at each end (i.e., throughsuturing) isolated in a bath 16 of Krebs solution. Electrode lead wires18 are Teflon-coated so as to act as insulation from the Krebs solutionto prevent shorting of electrical current. The setup 10 also includes asource 20 for providing electrical stimulation with varying parameters.Tension force of the strips are recorded using a transducer (e.g., forcegauge 21) and a computer obtains force data sensed by the transducer foranalysis and display. The following paragraphs describe force dataobtained from setups similar to that described with reference to FIG. 4,using tissue of pregnant patients in labor or after delivery.

FIG. 5 illustrates resulting force data from a test strip 12 of ratuterine tissue, when varying the stimulation current frequency (at 1 Hz,2 Hz, 3 Hz, and 5 Hz), with stimulation voltage and train durationfixed. Each frequency tested produced a visible contractile response,resulting in short stimulated phasic contractions. FIG. 6 illustratesresulting force data from a test strip 12 of human uterine tissue, withstimulation current frequency varied (at 1 Hz, 2 Hz, and 5 Hz), withstimulation voltage and train duration fixed. Each frequency testedproduced a short stimulated phasic contraction. FIG. 7 illustratesresulting force data from a test strip 12 of human uterine tissue, withstimulation current train duration varied (at 1 second, 2 seconds, 3seconds, 5 seconds, and 10 seconds), with stimulation voltage andfrequency fixed. No noticeable response was seen from 1-second and2-second train durations. However, train durations of 3 seconds, 5seconds, and 10 seconds produced short stimulated phasic contractions.The short stimulated phasic contractions shown in FIGS. 5-7, whileuseful for inducing or augmenting labor in women whose uterine functionis insufficient for successful labor and delivery, are not useful forstopping blood loss during uterine atony and postpartum hemorrhage.

FIG. 8 illustrates resulting force data from test and control strips 12of human myometrial tissue that were obtained from a term patient (39weeks gestation) who demonstrated insufficient contractile activityduring labor. Electrical stimulation at about 10 volts in pulses ofabout 2 Hz were applied to the test strip 12. The pulses were run for a5 minute duration (period 1), a 10 minute duration (period 2), and a 20minute duration (period 3). FIG. 8 shows spontaneous phasic contractileactivity in the control strip 12 (top trace, no outside electricalstimulation provided), and spontaneous phasic contractile activity aswell as stimulated phasic contractile activity in the test strip 12(bottom trace, outside electrical stimulation provided by the source20). The test strip 12 produced stimulated phasic contractile activityduring period 1, period 2, and period 3 as a result of direct electricalstimulation of the test tissue. The duration of the stimulated phasiccontractile activity was in direct proportion to the duration of theelectrical stimulation current applied, and when the electricalstimulation current was turned off, the test strip force measurementreturned fully to baseline, illustrating complete relaxation of thetissue.

The stimulated phasic contractile activity shown in FIG. 8 can beconsidered long stimulated phasic contractions, as the stimulationduration is longer than about 3 minutes and the stimulation frequencylies within the conventional uterine stimulation frequency range. Insome embodiments, long stimulated phasic contractions may be effectivefor reducing bleeding during postpartum hemorrhage and uterine atony,however, the amount of electrical energy required, and the length oftime that the uterine tissue is exposed to such energy, may be too largeto be of practical value in other embodiments.

FIG. 9 illustrates resulting force data from two test strips 12 of humanuterine tissue, with electrical stimulation frequencies varied (at 6 Hz,10 Hz, 20 Hz) and with electrical stimulation current pulse trainduration varied (at 60 seconds, 120 seconds, 300 seconds, 1200 seconds).Spikes shown in FIG. 9 indicate uterine muscle contractions. The spikeslabeled “P” indicate initial preparatory contractions. The spikeslabeled “S” indicate spontaneous uterine phasic contractions. The solidbars under the long spikes indicate the time periods during whichelectrical stimulation currents were applied to the uterine muscles.These time durations of electrical stimulation are indicated above thelong spikes (in seconds) following the letter “E”. While frequenciesgreater than or equal to about 5.0 Hz lie outside of the establishedrange of frequencies normally associated with uterine electricalactivity, they are capable of producing a muscle response in the form ofsustained uterine contractions. These contractions can be consideredtonic contractions (a type not observed during labor and delivery orusing electrical stimulation on the uterus within establishedfrequencies). As shown in FIG. 9, these tonic contractions remainforceful well after the treatment has stopped (i.e., after the appliedelectrical current has been turned off). In some embodiments, thesetonic contractions (i.e., forceful and sustained contractions) ortetanic contractions (i.e., tonic contractions which remain maximally,or near-maximally, forceful) can be very useful for stopping blood lossduring uterine atony and uterine rupture.

Tonic contractile events are not possible to achieve using conventionalelectrical stimulation parameters (i.e., 0.0 Hz to about 5.0 Hz), whichonly seem capable of producing phasic contractions of the type observedduring labor and delivery. Also, presently available drugs and systems,including oxytocin, are not capable of producing sustained, forcefulcontractions after treatment with them has completed. In someembodiments, only tonic contractions, achieved using frequencies at orabove about 5.0 Hz, can be useful for contracting the uterus duringcritical bleeding in women with uterine atony and/or uterine rupture.These types of contractions can help reduce the bleeding to allowdoctors enough time to stabilize the patient with other methods (e.g.,to suture the uterus if needed without having to perform more radicalsurgery, like a hysterectomy), or can help stop the bleeding completelyon their own.

FIG. 10 illustrates a system 22 according to one embodiment of theinvention. The system 22 can stimulate uterine muscles into toniccontractions using frequencies greater than about 5.0 Hz. The system 22can be used to stimulate muscles of the uterus in a way that does notaffect other organs and can be accurately regulated and controlled,unlike oxytocin or other conventionally-used drugs. The system 22 can beused on a patient, such as a female post-partum, and can be controlledby a user, such as a physician or medical staff member. For example, thesystem 22 can input innocuous electrical pulses into the patient'suterus with sufficient effect to incite postpartum tonic or tetaniccontractions in order to help treat uterine atony and postpartumhemorrhage. In some embodiments, the system 22 can include a controlmodule 24, a current source 26, an isolation unit 28, a constant maximumcurrent unit 30, a biphasic converter 32, a set of lead wires 34, and aset of electrodes 36.

The control module 24 can contain computing capability, software, andmemory. The control module 24 can be set using interface controls 33,such as dials, switches and/or auxiliary inputs, to performpreprogrammed stimulation tasks, including commanding the current source26 to output stimulation current of selected frequency, amplitude, pulsewidth, and train duration automatically for selected periods of time.The control module 24 can also be operated manually by the user, inwhich the user can determine and set one or more output stimulationcurrents of desired frequencies, amplitudes, pulse widths, and traindurations as needed spontaneously (i.e., in real time or in near-realtime). For example, the control module 24 can be operated automaticallyor manually to produce a stimulation current which can cause tonic ortetanic contractions of the patient's uterine muscle, and the user hasthe capability to adjust the stimulation current parameters (i.e.,frequencies, amplitudes, pulse widths, and/or train durations) in realtime or near-real time during observation of the patient's uterus.

In one embodiment, the control module 24 can automatically or manuallyoperate multiple stimulation outputs of the current source 26independently or in unison with varying or similar current frequencies,amplitudes, pulse widths, and train durations. As a result, the controlmodule 24 can provide stimulation currents directly to the uterus orthrough various organs, such as the cervix, vaginal wall and/orabdominal wall separately, simultaneously, or sequentially, or canprovide stimulation currents to various parts of the uterus separately,simultaneously, or sequentially.

In one embodiment, pre-recorded uterine electrical traces, obtained fromnormally contracting patients and saved digitally, can be stored in thecontrol module 24 to be used, in turn as the electrical current tracepatterns for commanding the current source 26 to output identicalstimulation current to patients with abnormal uterine activity, such aspatients with insufficient or absent contractile activity duringpostpartum hemorrhage. In addition, artificially generated currenttraces, saved digitally, with known frequencies, amplitudes, pulsewidths, and train durations, can be stored in the control module 24 tobe used as the electrical current trace patterns for commanding thecurrent source 26 to output identical stimulation current to patientswith abnormal uterine activity during postpartum hemorrhage.

In another embodiment, the control module 24 can automatically regulateand modify the electrical current output produced by the current source26 based on input from electrical contractile activity of the patient'suterus, which can be transmitted to the control module 24 via pick-upwires, a signal conditioner, and/or after-conditioning wires (notshown). The control module 24 can regulate and modify the producedelectrical current by changing the electrical stimulation pulse-width,current amplitude, pulse train duration, and/or the pulse frequencyaccording to a pre-programmed algorithm.

In some embodiments, the control module 24 can include a display 37 (asshown in FIG. 10), such as a video display, a digital display,light-emitting diode (LED) display, etc., to display the stimulationoutput currents produced for the user to read or assess. The controlmodule 24 can be coupled to the current source 26 by wires, directelectrical coupling, or another suitable coupling. For example, in oneembodiment, the control module 24 can communicate with the currentsource 26 via a wireless connection, such as Bluetooth®.

The current source 26 can generate the output stimulation current. Inone embodiment, the electrical stimulation current settings can beadjusted manually at the current source 26 by the user using interfacecontrols 35, such as dials, switches or other devices. In anotherembodiment, the electrical stimulation settings can be controlled by thecontrol module 24 (e.g., as preprogrammed settings or by the user usingthe interface controls 33, as described above), and output to thecurrent source 26. As described above, in some embodiments, the currentsource 26 can output multiple electrical stimulation currents eitherdirectly to the uterus or indirectly to the uterus via the cervix, thevaginal wall and/or the abdominal wall separately, simultaneously, orsequentially, as commanded by the control module 24, or the currentsource 26 can output multiple electrical stimulation currents to variouslocations of the uterus separately, simultaneously, or sequentially.

In some embodiments, there can be a constant two-way communicationbetween the current source 26 and the control module 24, so that thecurrent source 26 can receive commands from the control module 24 andthe control module 24 can receive actual output current values from thecurrent source 26.

In some embodiments, the current source 26 can be capable of generatingan output current between about 0.01 milliamperes and about 100.00milliamperes (with possible voltages between about 0.0001 volts andabout 100 volts). Pulse widths of the current can be adjusted betweenabout 0.1 millisecond and about 1000 milliseconds. Frequencies of thecurrent can be adjusted from about 0.1 Hertz to about 30 Hz or greater,or about 100 Hz or greater. Pulse train durations can be adjusted fromabout 1 second to about 10,000 seconds. In addition, output currents canbe sinusoidal so as to reduce tissue damage and maximize effect (10). Inone embodiment, the current source 26 can produce a maximal “jolt” ofuterine electrical stimulation energy equivalent to between about 1Joule and about 120 Joules of electrical energy in a short durationbetween about 1 millisecond and about 1000 milliseconds. Further, theelectrical stimulation current output from the current source 26 can besensed, measured, or detected by either the current source 26 or thecontrol module 24 and can be automatically shut off if current valuesare determined to be dangerous or outside prescribed, programmed, or setvalues.

The isolation unit 28 can prevent ground loop currents from affectingthe patient. In one embodiment, isolation is accomplished throughoptical isolation. In other embodiments, induction or other methods ofisolation can be used by the isolation unit 28.

The constant maximum current unit 30 can allow the user to regulate theamount of maximum current that the patient's uterus receives. Theconstant maximum current unit 30 can prevent tissue damage due toextreme current fluctuations as tissue resistance varies (11), and canbe set (either in a discrete or continuous fashion) to or between valueswell below human threshold for human feeling (e.g., about 0.01milliamperes) and values uncomfortable for humans (e.g., about 100milliamperes). In one example, the constant maximum stimulation currentcan be set at a value which maximizes current input without damagingtissue and with minimal discomfort to the patient (e.g., about 4milliamperes).

The biphasic converter 32 can alternate the polarity of current pulsesproduced by the current source 26 after having moved through theisolation unit 28 and the constant maximum current unit 30 in order tofurther prevent adverse effects on the patient's tissues. The biphasicconverter 32 can insure that the total energy delivered at the tissuesite, as integrated over time, has a net value of zero. This can reducethe possibility of heating and subsequent damage to the patient'stissues (11, 12).

The lead wires 34 can transmit the output current from the biphasicconverter 32 to the electrodes 36. In one embodiment, the lead wires 34can be those manufactured by Advantage Medical Cables or similardevices. In some embodiments, the system 22 can include between one andfifty lead wires 34. For example, different lead wires 34 can carrydifferent types or strengths of currents that incite, induce, or augmenta tonic contraction at different times in different parts of the uterus,as preprogrammed or set by the user (e.g., to stimulate various parts ofthe patient's uterus separately, simultaneously, and/or sequentially).In some embodiments, the lead wires 34 can be insulated.

FIG. 11 illustrates a patient's uterus 38, ovaries 40, fallopian tubes42, a uterine body (or intrauterine cavity) 44, a cervix 46, a vagina48, a fundus 50 (i.e., top portion) of the uterus, and a distal portion52 of the uterus. The electrodes 36 can be attached to or near theuterus 38 in a specific orientation and at specific locations that willhave the best effect upon uterine contractility for the patient, asdetermined by the user. In one example, the electrodes 36 can be placedupon the vaginal wall 48 and/or the cervix 46. In another example, theelectrodes 36 can be placed at locations across the fundal portion 50and distal portion 52 of the uterus 38. Also, the electrodes 36 can bemounted externally to the patient's abdominal surface.

The electrodes 36 can be attached to the patient's abdominal surfaceand/or uterus 38 using biocompatible glue or tissue adhesive, or bysuction or other self-affixing electrodes. In one embodiment, theelectrodes 36 can be standard silver chloride (AG2Cl) electrodes, EEGelectrodes, suction electrodes, or needle electrodes. In someembodiments, the system 22 can include between one and fifty electrodes36 (e.g., equal to the number of lead wires 34). Different electrodes 36can be positioned at various locations in or around the patient's uterus38, where some or each of the electrodes 36 causes tonic and/or phasiceffects according to the electrical stimulus applied through them. Forexample, one or several electrodes 36 can act as a local pacemaker foreliciting contractions, while one or several other electrodes 36 cancover one or many different portions of the uterus 38 for elicitingglobal tonic or tetanic contractions. In addition, in some embodiments,the electrodes 36 can consist of platinum-iridium metals, so as toreduce the possibility of tissue lesions (12).

FIGS. 12A-12C illustrate a patient's uterus 38 in three differentconditions. FIG. 12A shows a naturally contracting uterus 38post-partum. Forceful and spontaneous tonic contractions can preventblood loss. FIG. 12B shows a uterus 38 which is not contractingpostpartum due to uterine atony. The lack of tonic contractile activityallows the uterus to bleed out, threatening the life of the patient.FIG. 12C shows the uterus 38 with atony and uterine rupture treatedeffectively (i.e., forcefully contracted) using electrical tonicstimulation. As shown in FIG. 12C the uterus 38 has been outfitted withelectrodes 36 (trans-vaginally) so that the system 22 can outputstimulated current (i.e., through the lead wires 34) for tonic activityusing electrical frequencies greater than or equal to about 5 Hz. Theartificially-stimulated tonic contractions can help reduce, stop and/ormanage the blood loss. In one embodiment, the stimulated current can beoutput to the patient for a duration greater than about 10 seconds. Insome embodiments, the pulse train durations can be up to about 30minutes long.

In addition, the system 22 can be used in conjunction with otherdevices, methods, systems, and treatments for postpartum hemorrhage,uterine atony, and bleeding or coagulation problems, including but notlimited to oxytocin, prostaglandins, misoprostol, prepidil, ergotalkyloids, tamponades, balloon tamponades, sponges, clamps, manualuterine massage and manipulation, sutures, bio-compatible adhesives,cauterization, and/or pharmaceutical coagulants.

In some embodiments, the system 22 can include one or more devices forpositioning the electrodes 36 within a patient's uterus, as describedbelow. For example, in some embodiments, the system 22 can include aballoon electrode array device 54, as shown in FIGS. 13-14B, outfittedwith the lead wires 34 and the electrodes 36. The balloon electrodearray device 54 can be used to assist with reducing blood flow from theuterus 38 during postpartum hemorrhage through mechanical pressure aswell as electrical stimulation (i.e., using stimulation frequenciesgreater than or equal to about 5 Hz for inducing tonic or tetaniccontractions). Also, in some embodiments, the balloon electrode arraydevice 54 can be used to assist with inducing contractions in laboringwomen (i.e., using conventional stimulation frequencies for inducingstimulated phasic contractions).

The balloon electrode array device 54 can include a balloon, orconcentric balloons, which can be inserted trans-vaginally andtrans-cervically. The balloon electrode array device 54 can beinflatable (in order to apply mechanical pressure to the inside wall ofthe uterus 38) and can alternatively or simultaneously apply electricalstimulation to contract uterine muscle and/or arteries. The inflation ofthe balloon can provide a reliable contact of the attached stimulatingelectrodes 36 to the internal surface of the uterus 38. In oneembodiment, the balloon electrode array device 54 can be a dual balloonelectrode array and internal pressure intrauterine device, as shown inFIG. 13. In one embodiment, the balloon electrode array device 54 caninclude an outer balloon 56, an inner balloon 58, a set of insulatedlead wires 34, a semi-rigid core 60, an inflation/wiring access tube 62,a set of electrodes 36, and a drainage tube (not shown).

In some embodiments, the outer balloon 56 can be made of latex, rubber,silicone, or another biocompatible stretchable polymer or plastic. Theouter balloon 56 can be fitted on its outer surface with an arrangementof one or more electrodes 36, which can be distributed evenly about aportion of the outer surface, as shown in FIG. 13. The number ofelectrodes 36 can be varied in different embodiments. A conductiveportion of the electrodes 36 can protrude through the outer surface toan inner surface of the outer balloon 56.

In some embodiments, the inner balloon 58 can be made of the samematerial as the outer balloon 56 (e.g., latex, rubber, silicone, oranother biocompatible stretchable polymer or plastic). The inner balloon58 can be airtight and watertight and can be inflated with an inflatingmaterial such as a liquid or a gas (e.g., saline, water, or air), asshown in FIG. 14A. Inflation of the inner balloon 58 can cause the outerballoon 56 to also expand. In one embodiment, the balloon electrodearray device 54 does not include the inner balloon 58, and the outerballoon 56 can be watertight, airtight, and inflatable (i.e., as asingle balloon electrode array and internal pressure intrauterinedevice).

The set of insulated lead wires 34 can equal the number of electrodes36, with each individual lead wire 34 carrying electrical stimulationcurrent to an individual electrode 36 fitted in, on, and/or through theouter balloon 56. In one embodiment, each lead wire 34 can be connectedto its respective electrode 36 via the conductive portion of theelectrode 36 protruding through the outer balloon 58. In addition, theset of lead wires 34 can be positioned in between the inner balloon 58and the outer balloon 56 (i.e., along the outside of the inner balloon58 and on the inside of the outer balloon 56), so that the lead wires 34do not come into contact with the patient's uterus 38.

The semi-rigid core 60 can be rigid enough to facilitate the insertionof the device 54 through the vaginal canal, through the cervix, and intothe intrauterine cavity (i.e., in a deflated state, as shown in FIG.14A), but not so rigid as to cause the balloon electrode array device 54to perforate the uterine tissue when inserted into the uterus 38. Insome embodiments, the semi-rigid core 60 can be hollow, flexible tubingmade of rubber, plastic, Tygon®, or other similar materials. Also, inone embodiment, the balloon electrode array device 54 is capable ofbeing placed into the uterus manually by hand without requiring thesemi-rigid core 60.

The inflation/wiring access tube 62 can serve as a conduit forintroducing the inflating material into the inner balloon 58 (or theouter balloon 56 in some embodiments) and for at least partially routingthe set of lead wires 34 from the balloon electrode array device 54 toan external electrical current and voltage source (e.g., indirectly tothe current source 26 through the biphasic converter 32 of the system22, as described above). The drainage tube (not shown) can be used formonitoring and measuring blood flow from the uterus 38. In someembodiments, the balloon electrode array device 54 may not include thedrainage tube.

As described above, electrical muscle stimulation can provide a way tospecifically apply different contractile effects locally on the uterus38. The balloon electrode array device 54 (or the other electrode arraydevices described below) can be used with the system 22 to aid instimulating uterine contractions at a controllable rate and acontrollable strength, as determined by the user, for example, to helpproduce more contractions or more powerful contractions for efficientand safer deliveries for women in labor or to help incite life-savinguterine contractions in critical hemorrhaging patients after delivery tohelp treat uterine atony. In the case of hemorrhage and uterine atony,the applied pressure to the cervical area 46, vaginal area 48 and/orintrauterine cavity 44 as a result of inflating the outer balloon 60 canact as an external aid to help control bleeding while the stimulationcurrents can help incite the patient's natural response to controlbleeding (i.e., through tonic contractions of the uterine muscles).Further, in some embodiments, the balloon electrode array device 54 canbe used to aid in cervical ripening to help induce labor. The inflatedballoon electrode array device 54 can apply pressure to the cervix 46 tohelp soften the cervix and incite dilation.

In some embodiments, the system 22 can include a ring electrode arraydevice 64, as shown in FIGS. 15A-16B. The ring electrode array device 64can be a flexible ring outfitted with lead wires 34 and electrodes 36and inserted trans-vaginally for assisting with reducing blood flow fromthe uterus 38 during postpartum hemorrhage through electricalstimulation (i.e., using stimulation frequencies greater than or equalto about 5 Hz for inducing tonic or tetanic contractions). Also, in someembodiments, the ring electrode array device 64 can be used to assistwith inducing contractions in laboring women (i.e., using conventionalstimulation frequencies for inducing stimulated phasic contractions).

The ring electrode array device 64 can include a ring 66, a set ofelectrodes 36, and a set of insulated lead wires 34. The ring 66 cancomprise ring-shaped or torus-shaped rubber, latex, silicone, Tygon®, ora similar medical grade flexible material which is biocompatible. Theset of electrodes 36 can be affixed to the outer surface of the ring 66,or embedded within or incorporated into the ring material so that theelectrodes 36 are exposed at an outer surface of the ring 66. The leadwires 34 can be completely external to the ring material or partlyaffixed to or embedded in the ring material. In some embodiments, theset of lead wires 34 can be separately coupled directly to the system 22(e.g., to the biphasic converter 32). In other embodiments, the set oflead wires 34 can be separately coupled to a lead cable connector 68, asshown in FIG. 15A, which can be permanently or releasably coupled to thesystem 22. For example, the ring electrode array device 64 can bedisposable so that, after stimulation, the lead wires 34 can bedisconnected from the lead cable connector 68 and the entire device 64disposed of.

In other embodiments, some or all of the lead wires 34 can be bundledinto an applicator 70, as shown in FIGS. 16A and 16B, and coupled to thesystem 22 (either directly or via the lead cable connector 68). Theapplicator 70 can be a rigid or semi-rigid cylindrical probe (made ofmetal, rigid plastic, etc.) and, in some embodiments, can be coupled tothe ring 66. The applicator 70 can be permanently coupled to the ring 66(e.g., by an affixing structure 71, as shown in FIG. 16B) or can bedetached from the ring 66 and removable. In addition, in one embodiment,the ring 66 can be collapsed into the applicator 70 or around an outsideportion of the applicator 70. For example, the ring can be collapsedinto the applicator 70 and the lead wires 34 can be bundled into theapplicator 70 for ease of insertion trans-vaginally. If the applicator70 is not used, the ring 66 can be inserted manually by hand, forexample by first collapsing the ring 66 manually.

The ring 66 can be positioned in the vaginal canal against the cervix 46or formix during application of electrical stimulation (i.e., usingstimulation frequencies greater than or equal to about 5 Hz) in order toallow electrical current to flow between adjacent electrodes 36, andindirectly through the uterus 38 and/or through the uterine artery, thusinitiating contractile activity of the uterus 38 or arteries sufficientto reduce bleeding (e.g., during uterine atony or postpartumhemorrhage). If the applicator 70 is permanently coupled to the ring 66,as shown in FIG. 16B, it can remain within the vaginal canal duringelectrical stimulation of the electrodes 36. If the applicator 70 isdetachable from the ring 66, as shown in FIG. 16A, it can be removedprior to electrical stimulation, if desired. In some embodiments, thedevice 64, including the applicator 70, can be disposable. In otherembodiments, at least some components of the device 64, such as theapplicator 70, can be sterilizable for multiple uses.

In addition, the ring electrode array device 64 can be capable ofdelivering medication (i.e., via absorption) to the uterus 38 orsurrounding tissue, simultaneous to the uterine electrical stimulation.The medication can be impregnated into and gradually released from thering 66.

In some embodiments, the system 22 can include an electrode probe device72, as shown in FIGS. 17A-17C. The electrode probe device 72 can be arigid or semi-rigid cylindrical probe 74, outfitted with the electrodes36 at one end and the connecting lead wires 34 within the probe 74extending out at another end and inserted trans-vaginally for assistingwith reducing blood flow from the uterus 38 during postpartum hemorrhagethrough electrical stimulation (i.e., using stimulation frequenciesgreater than or equal to about 5 Hz for inducing tonic or tetaniccontractions). Also, in some embodiments, the electrode probe device 72can be used to assist with inducing contractions in laboring women(i.e., using conventional stimulation frequencies for inducingstimulated phasic contractions).

The electrode probe device 72 can include a probe 74 comprising rubber,latex, Tygon®, metal, plastic, or a similar material, generally in theshape of a hollow or substantially solid cylinder. The electrode probedevice 72 can include electrodes 36 affixed to an outer surface end ofthe probe 74. The electrodes 36 can be embedded within or incorporatedinto the probe 74 so that the electrodes 36 are exposed at the outersurface end of the probe 74. In addition, the electrode probe device 72can include insulated lead wires 34 for transmitting electrical currentto the electrodes 36. The lead wires 34 can be partially coupled to orembedded in the probe 74. For example, the lead wires 34 can be routedthrough a hollow tube within the probe 74 so that one end of each leadwire 34 is attached to an electrode 36 and another end of each lead wire34 is coupled to an electrical lead cable (e.g., similar to the leadcable connector 68, as shown in FIG. 15A, connected to the system 22).In addition, all or at least some of the lead wires 34 can be bundledtogether and routed through a hollow tube within the probe 74.

The electrode probe device 72 can be positioned through the vaginalcanal so that the electrodes 36 are positioned against or into thetissues of the cervix or formix, or through the cervix 46 into theuterine cavity and positioned directly against or into the inner uterinewall. Application of electrical stimulation (i.e., using stimulationfrequencies greater than or equal to about 5 Hz) can allow electricalcurrent to flow between adjacent electrodes 36, and thus flow indirectlyor directly through the uterus and/or through the uterine artery, thusinitiating contractile activity of the uterus or arteries sufficient toreduce bleeding (e.g., during uterine atony or postpartum hemorrhage).

In some embodiments, the entire device 72 can be disposable. In otherembodiments, at least some components of the device 72 can besterilizable for multiple uses. In one embodiment, as shown in FIG. 17A,the probe 74 can include a single spiral electrode 34 protruding fromone end, and lead wires 34 routed through a hollow portion of the probe74. In another embodiment, as shown in FIG. 17B, the probe 74 caninclude one or more “bar” or “rod” electrodes 36 protruding from oneend. In yet another embodiment, as shown in FIG. 17C, the probe 74 caninclude one or more “barb” or “needle” electrodes 36 protruding from oneend. In some embodiments, multiple probes 74 can be used simultaneously,as needed, to apply sufficient electrical current in a sufficient numberof locations on the uterus, cervix, or formix in order to produce anadequate uterine contractile response.

In addition, the electrode probe device 72 can be capable of deliveringmedication (i.e., via injection) to the uterus 38 or surrounding tissue,simultaneous to the uterine electrical stimulation.

In some embodiments, the system 22 can include a mesh electrode arraydevice 76, as shown in FIGS. 18A-20C. The mesh electrode array device 76can comprise an array of electrodes 36 in the form of a “net,” “web,” or“mesh” 78 of electrically non-conductive, flexible, and/or stretchablematerial supporting the conductive electrode elements 36 and/orconductive lead wires 34. The mesh electrode array device 76 can beinserted trans-vaginally for assisting with reducing blood flow from theuterus 38 during postpartum hemorrhage through electrical stimulation(i.e., using stimulation frequencies greater than or equal to about 5 Hzfor inducing tonic or tetanic contractions). Also, in some embodiments,the mesh electrode array device 76 can be used to assist with inducingcontractions in laboring women (i.e., using conventional stimulationfrequencies for inducing stimulated phasic contractions).

The non-conductive mesh material 78 can provide a framework tonon-conductively connect or link each electrode 36 to one or more otherelectrodes 36. The non-conductive mesh material 78 can be a supportingsubstrate having one or more segments constructed of flat, rounded,cylindrical, and/or other-shaped material. In some embodiments, thenon-conductive mesh material 78 can comprise silicone, latex, rubber,plastic, nylon, etc., so that the device 76 can stretch and twisteffectively in multiple directions. In addition, the non-conductive meshmaterial 78 can be fabricated to include a constant or variableframework or base structure, including square, hexagonal, triangular,and/or other mesh shapes, as shown in FIGS. 18A and 18B.

The mesh electrode array device 76 can expand (e.g., substantially openup, unfold, stretch out, etc.) to a size sufficient to cover, envelope,or encircle the uterus 38. The device 76 can expand into a generalsphere, general ovoid, or general cigar shape, having dimensions betweenabout 5 centimeters major or minor diameter up to about 50 centimetersmajor or minor diameter. For example, in one embodiment, the device 76can be fabricated to form-fit snugly around the entire outer surface ofa uterus 38 before and/or after delivery of the fetus bycesarean-section. In addition, the non-conductive mesh material 78 caninclude gaps, slits, or other openings positioned therein in order toaccommodate uterine arteries and various ligaments when deployed ontothe uterus 38. The device 76 can also be specifically fabricated invarious sizes in order to accommodate, as appropriate, either a small,medium, or large size uterus 38.

The electrodes 36 can be positioned along and within the non-conductivemesh material 78 at nodes of intersection of the strands or segmentsand/or along the length of the strands or segments. The electrodes 36can include materials which are electrically conductive, such as metal,graphite, ceramic, polymer, or other rigid or semi-rigid and conductivesubstances. In some embodiments, as shown in FIG. 19, each electrode 36can include a tip 80 and a housing 82 coupled together mechanically orchemically. The tip 80 (e.g., a conductive portion) can be connected toor positioned on the uterine tissue for passing electrical currentthereto, and the housing 82 (e.g., an electrically non-conductiveportion) can be coupled to the non-conductive mesh material 78. Thehousings 82 can include a rigid or semi-rigid electricallynon-conductive material, such as plastic, rubber, polymer, etc., and caninclude passages, gaps, grooves, and/or ridges through which or intowhich the lead wires 34 can pass to electrically connect with the tips80. As shown in FIG. 19, the electrodes 36 can include one or moreshapes, such as needles, spikes, point, nubs, grommets, nipples, disks,or any other form, feature, or shape to provide sufficient electricalconductivity and connectivity between the electrodes 36 and the uterinetissue, and to transmit electrical current to/from the electrodes 36 anduterine tissue. The above-described shapes of electrodes 36 can beincorporated into one or more of the devices 54, 64, 72, 76 in someembodiments.

The mesh electrode array device 76 can include sufficient tensilestrength and elastic force so that a physician can fully and manuallydeploy it around and onto the uterus 38 with relative ease by hand withminimal risk of injury to the patient and to the physician duringhandling and deployment. In addition, the electrodes 36 can be orientedin such a way within and on the non-conductive mesh material 78 so thatthe tips 80 are directed toward the uterine tissue when the device 76 isdeployed (e.g., placed onto and expanded around the outer surface of theuterus 38, for example during cesarean section). More specifically, themesh electrode array device 76 can include sufficient tensile strengthand elastic force so that when the device 76 is deployed, the electrodes36 will rest firmly against the outer surface of the uterus 38, or sothat portions of the electrodes 36 will penetrate through an outermembrane of the outer surface of the uterus 38 (e.g., when usingneedle-shaped or other pointed-tip types of electrodes 36).

In some embodiments, the mesh electrode array device 76 can includepairs of electrodes 36 (e.g., each pair including a positive electrodeand a negative electrode), with each pair of electrodes 36 capable oftransmitting an individual, distinct electrical current through theuterine tissue. The electrodes can receive electrical stimulationcurrent (e.g., can be electrically activated by and fed electricalstimulation current from the system 22) via two or more lead wires 34(e.g., at least one positive lead wire 34 and at least one negative leadwire 34).

For example, the designated positive electrodes 36 (e.g., from theelectrode pairs) can receive electrical stimulation current from asingle main positive voltage lead wire 34, and the designated negativeelectrodes 36 can receive electrical stimulation current from a singlemain negative voltage lead wire 34, as shown in FIG. 20A. In anotherexample, the designated positive electrodes 36 can receive electricalstimulation current from different positive voltage lead wires 34, whichare branched off from the single main positive voltage lead wire 34, andthe designated negative electrodes 36 can receive electrical stimulationcurrent from different negative voltage lead wires 34, which arebranched off from the single main negative voltage lead wire 34, asshown in FIG. 20B. In yet another example, the designated positiveelectrodes 36 can receive electrical stimulation current from separate,individual positive voltage lead wires 34, and the designated negativeelectrodes 36 can receive electrical stimulation current from separate,individual negative voltage lead wires 34, as shown in FIG. 20C.

In some embodiments, at least some portions of the electrodes 36 (e.g.,the tips 80 or other portions) of the above-described devices 54, 64,72, 76, can be fitted with, covered by, coated with, or impregnated withconductive epoxy, medication, friction-reducing compounds, or othersubstances for improving the electrical conductivity between theelectrode 36 and the uterine tissue, for treating the patient or theuterus, for improving the effect of electrical stimulation of the uterus38, for improving uterine contractility, and/or for enhancing the easewith which electrodes 36 are applied to or into the uterine tissue. Inaddition, at least some portions of the electrodes 36 (e.g., the tips 80or other portions) can be fitted with, covered by, coated with, orimpregnated with insulating epoxy, friction-reducing compounds, or othersubstances (e.g., polytetrafluoroethylene, or PTFE, resin) foreliminating or reducing electrical conductivity and contact between suchportions of the electrodes 36 and the uterine tissue.

In addition, in some embodiments, the electrodes 36 of theabove-described devices 54, 64, 72, 76 can be temporarily covered bytabs, covers, or safety guards (not shown) for protecting the patientand user from punctures or cuts during handling prior to or duringdeployment of the devices 54, 64, 72, 76. The safety guards canindividually be removed manually upon, after, or prior to deploying thedevice, and can be replaced, if desired.

In some embodiments, the above-described devices 54, 64, 72, 76 or otherexternal, internal, or transvaginally, transcervically, percutaneously,or transabdomoinally placed needles, catheters, probes, electrodes orelectrode arrays may be outfitted with the cable connector 68 or asimilar device in order to be coupled to the system 22 for receivingelectrical stimulation current (e.g., from the biphasic converter 32)via a connector and cable device 84, as shown in FIGS. 21A-23B. Thedevice 84 can include a lead wire connector plug 86, an electronicsconnector plug 88, and a flexible, electrically insulated cable 90.

In one embodiment, the electronics connector plug 88 can connect to thebiphasic converter 32 for receiving electrical stimulation current. Inanother embodiment, components of the system 22 (e.g., the controlmodule 24, the current source 26, the isolation unit 28, the constantmaximum current unit 30, the biphasic converter 32) can be housed in asingle electronics box (not shown) and the electronics connector plug 88can be connected to the electronics box for receiving electricalstimulation current. The electrical stimulation current can be routedfrom the electronics connector plug 88 to the lead wire connector plug86 via the cable 90. In some embodiments, the plugs 86 and 88, and thecable 90 can be permanently coupled as a single unit. In otherembodiments, the plugs 86 and 88, and the cable 90 can be releasablycoupled together, for example so that some portions can be disposableand some portions can be sterilizable (e.g., using radiation, gas,and/or heat).

In some embodiments, the lead wire connector plug 86 and/or theelectronics connector plug 88 can comprise conventional connector plugs,such as DIN connectors, BNC connectors, coaxial connectors, bananaconnectors, LEMO connectors, etc., for connecting to the lead wires 34and/or the electronics box, respectively. In some embodiments, the leadwire connector plug 86 and/or the electronics connector plug 88 cancomprise a pin connector array, as described below. For example, FIG.21A illustrates the lead wire connector plug 86 and the electronicsconnector plug 88 as a generic connector and a pin connector array,respectively. FIG. 21B illustrates both the lead wire connector plug 86and the electronics connector plug 88 as pin connector arrays.

The pin connector array can include a plurality of pin connectors, asshown in FIGS. 22A and 22B. In one embodiment, each pin connector cancomprise an irregular, symmetric hexagonal shape, as shown in FIG. 23A.For example, the hexagonal shape can take the form of an equilateraltriangle of length L, with wedges (length ¼L) at each vertex of theequilateral triangle removed, as shown in FIG. 23B. In otherembodiments, the pin connectors can comprise other shapes.

The pin connectors can be positioned relative to each other on the pinconnector array in one or more arrangements, as shown in FIGS. 22A and22B. For example, the “flip flop” arrangement illustrated in FIG. 22Bcan be substantially shorter than the “in-line” arrangement illustratedin FIG. 22A. In addition, FIGS. 22A and 22B show 10 pin connectors ineach pin connector array. In some embodiments, the pin connector arrayscan include one to fifty or more pin connectors.

In one embodiment, the electronics box and/or the lead wires 34 caninclude corresponding male connectors for receiving the pin connectors(e.g., female connectors) of the plugs 86, 88. In another embodiment,the electronics box and/or the lead wires 34 can include correspondingfemale connectors for receiving the pin connectors (e.g., maleconnectors) of the plugs 86, 88. In either embodiment, the maleconnectors can include a cylindrical pin protruding from the generalcenter of the hexagonal shaped connector, as shown in FIG. 24A. The pincan include an outside diameter between about 1.245 millimeters andabout 1.255 millimeters in some embodiments. The female connectors caninclude mating cylindrical holes for the cylindrical pins of the maleconnectors, as shown in FIG. 24B. The holes can include an innerdiameter between about 1.245 millimeters and about 1.255 millimeters insome embodiments. In addition, the pin connectors can be plastic, whilethe protruding pins can be metallic and the holes can include metallicinternal sleeves. The pins and internal sleeves can also comprise otherconductive materials in some embodiments. In addition, the pin connectorarrays or the individual pin connectors can include one or more lockingmechanisms. In one embodiment, the locking mechanism, either on theplastic or the conductive portions of the pin connectors, cansubstantially lock the pin connector arrays in place when the femaleconnectors and the male connectors are connected. Once connected, thefemale connectors and the male connectors can be broken or disabled whenseparated, ensuring one-time use of the pin connector arrays.

In some embodiments, the cable 90 can include a plurality ofelectrically conductive materials or wires (e.g., metal, carbon-basedelements, etc.). The electrically conductive wires can be substantiallyflexible and bunched, threaded, braided, or twisted through the cable90. The electrically conductive wires can be electrically insulatedexternally by materials such as plastic, rubber, silicone, or othernon-conductive media. Each hole in the pin connector array (of thefemale connectors) at the plug 86 can be associated with a separateelectrically conductive wire, which can be connected to an associatedpin or sleeve (of the male connectors or the female connectors,respectively) at the plug 88.

In some embodiments, the connector and cable device 84 can includeelectrical circuitry, computer software or hardware, logic circuits,instructions, codes, and/or programs stored in memory and executable bythe electrical circuitry, which can serve one or more of followingfunctions: measuring or communicating electrical impedance values (inthe patient, between electrodes 36, and/or between the patient andelectrodes 36); determining or communicating the electrical or physicalintegrity of the cable 90, the plugs 86, 88, and/or any of theelectrodes 36; communicating an embedded serial code, license code,model number, or other electronically stored or coded information aboutthe connector and cable device 84 to the electronics in the system 22;and preventing the operation of providing electrical stimulation currentif cable or plug portions become detached, separated, broken,compromised, or otherwise altered, or if the serial code is not corrector identifiable by the system 22.

The present invention has been described in terms of one or morepreferred embodiments, and it should be appreciated that manyequivalents, alternatives, variations, and modifications, aside fromthose expressly stated, are possible and within the scope of theinvention.

The entire disclosure of each patent and publication cited herein isincorporated by reference, as if each such patent or publication wereindividually incorporated by reference herein. Unless defined otherwise,technical and scientific terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thisinvention belongs. Singleton et al., Dictionary of Microbiology andMolecular Biology 3rd ed., J. Wiley & Sons (New York, N.Y. 2001); March,Advanced Organic Chemistry Reactions, Mechanisms and Structure 5th ed.,J. Wiley & Sons (New York, N.Y. 2001); and Sambrook and Russel,Molecular Cloning: A Laboratory Manual 3rd ed., Cold Spring HarborLaboratory Press (Cold Spring Harbor, N.Y. 2001), provide one skilled inthe art with a general guide to many of the terms used in the presentapplication.

REFERENCES

-   1. The Prevention and Management of Postpartum Haemorrhage: Report    of Technical Working Group, Geneva 3-6 Jul. 1989. Geneva: World    Health Organization, 1990.-   2. Elbourne D R, Prendiville W J, Carroli G, Wood J, McDonald S.    Prophylactic use of oxytocin in the third stage of labour. Cochrane    Database Syst Rev 2001; (4): CD001808.-   3. Bais J M, Eskes M, Pel M, Bonsel G J, Bieker O P. Postpartum    haemorrhage in nulliparous women: incidence and risk factors in low    and high risk women. A Dutch population-based cohort study on    standard(>=500 mL) and severe(>=1000 mL) postpartum haemorrhage. Eur    J Obstet Gynecol Reprod Biol 2004; 115:166-72.-   4. Reyal F, Deffarges J, Luton D, Blot P, Oury J F, Sibony O. Severe    post-partum hemorrhage: descriptive study at the Robert-Debre    Hospital maternity ward [French]. J Gynecol Obstet Biol Reprod    (Paris) 2002; 31:358-64.-   5. Norris T C. Management of postpartum hemorrhage. Am Fam    Physician. 1997 Feb. 1; 55(2):635-40.-   6. Fawcus, S, Mbizvo, M, Lindmark, G, Nystrom, L. A community-based    investigation of maternal mortality from obstetric haemorrhage in    rural Zimbabwe. Maternal Mortality Study Group. Trop Doct. 1997    July; 27(3):159-63.-   7. Sultatos L G. Mechanisms of drugs that affect uterine motility. J    Nurse Midwifery. 1997 July-August; 42(4):367-70.-   8. Alexander E. Weingarten, M D, Jeffrey I. Korsh, M D, George G.    Neuman, M D, and Steven B. Stem, M D. Postpartum Uterine Atony after    Intravenous Dantrolene. Anesth Analg 1987; 66:269-270.-   9. Hacker, Neville, J. G. Moore, and Joseph Gambone. Essentials of    Obstetrics and Gynecology. 4th ed. Vol. 1. Philadelphia: Elsevier    Inc., 2004. 151.-   10. Bennie S D, Petrofsky J S, Nisperos J, Tsurudome M, Laymon M.    Eur J Appl Physiol. 2002 November; 88(1-2):13-9. Epub 2002 Sep. 10.    Toward the optimal waveform for electrical stimulation of human    muscle.-   11. DeLisa, Joel A.; Gans, Bruce M.; Walsh, Nicolas E.; Bockenek,    William L.; Frontera, Walter R.; Gerber, Lynn H.; Geiringer, Steve    R.; Pease, William S.; Robinson, Lawrence R.; Smith, Jay; Stitik,    Todd P.; Zafonte, Ross D. Physical Medicine and Rehabilitation:    Principles and Practice. 4th edition. 2004. Lippincott Williams &    Wilkins (LWW): Chapter 66.-   12. Piallat B, Chabardes S, Devergnas A, Torres N, Allain M, Barrat    E, Benabid A L. Monophasic but not biphasic pulses induce brain    tissue damage during monopolar high-frequency deep brain    stimulation. Neurosurgery. 2009 January; 64(1):156-62; discussion    162-3.

1. A balloon electrode array device configured to apply stimulatingcurrent to a patient for treating insufficient uterine contractions, theballoon electrode array device comprising: at least one balloon; anaccess tube extending into the at least one balloon; a plurality of leadwires routed through the access tube and into an inside portion of theballoon; and a plurality of electrodes, each one of the plurality ofelectrodes coupled to one of the plurality of lead wires, the pluralityof electrodes extending from the inside portion of the balloon to anouter surface of the balloon.
 2. The balloon electrode array device asrecited in claim 1 further comprising a core extending into the insideportion of the balloon.
 3. The balloon electrode array device as recitedin claim 2 in which the core comprises a semi-rigid material.
 4. Theballoon electrode array device as recited in claim 1 in which the atleast one balloon is constructed of at least one of latex, rubber,silicone, and a biocompatible stretchable polymer.
 5. The balloonelectrode array device as recited in claim 1 in which the at least oneballoon is inflatable via an inflating material introduced through theaccess tube.
 6. The balloon electrode array device as recited in claim 1in which the at least one balloon includes an outer balloon and an innerballoon.
 7. The balloon electrode array device as recited in claim 1 inwhich a conductive portion of each of the plurality of electrodesextends from the inside portion of the balloon to the outer surface ofthe balloon.
 8. The balloon electrode array device as recited in claim 1further comprising a drainage tube.
 9. The balloon electrode arraydevice as recited in claim 1 wherein the plurality of electrodes arecoated with and used to administer a medication.
 10. (canceled) 11.(canceled)
 12. (canceled)
 13. (canceled)
 14. (canceled)
 15. (canceled)16. (canceled)
 17. (canceled)
 18. (canceled)
 19. (canceled) 20.(canceled)
 21. (canceled)
 22. (canceled)
 23. (canceled)
 24. (canceled)25. A method for treating insufficient uterine contractions after laborand delivery, the method comprising: generating electrical stimulatingcurrent signals at a frequency between about 5.0 Hertz and about 100Hertz; and applying the electrical stimulating current signals to one ofa cervix, a vagina, and a uterus using one of a balloon electrode arraydevice, a mesh electrode array device, an electrode probe device, and aring electrode array device to produce uterine tonic contractions.
 26. Asystem for treating insufficient uterine contractions in a patient afterlabor and delivery, the system comprising: a control module whichperforms at least one of preprogrammed stimulation tasks anduser-defined stimulation tasks; a current source controlled by thecontrol module to produce stimulating current at a frequency betweenabout 5.0 Hertz and about 100 Hertz; one of a balloon electrode arraydevice, a mesh electrode array device, an electrode probe device, and aring electrode array device coupled to one of a uterus, a cervix, avaginal wall, and an abdominal wall of the patient to provide thestimulating current to the patient in order for the patient to producetonic uterine contractions.